MELBOURNE, Australia , Aug. 28, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has submitted a New Drug Application (NDA) to the United States (U.S.
) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara® [1] , 18 F-floretyrosine or 18 F-FET), an investigational PET [2] agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients. Given the potential to address significant unmet medical need, Pixclara® 1 has been granted Orphan Drug [3] and Fast Track [4] designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process. FET PET (Pixclara® 1 ) is already included in international clinical practice guidelines for the imaging of gliomas [5] , however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.
S. There is a critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. With low survival rates and the need to make rapid decisions, precision imaging is paramount.
Subject to regulatory approval, Pixclara® 1 has the potential to address this need, enabling patients to receive greater clarity in their diagnosis and treatment decision making. Pixclara® 1 is also being developed as the "companion" theranostic imaging agent for T.